Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation

Agitation,Psychomotor Clinical Trial

— MOHZA  

Official title:

Prospective Observational Investigation of Olanzapine Versus Haloperidol Versus Ziprasidone Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211897
• Other study ID #: HSR # 17-4345
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: March 14, 2018
• Start date: June 15, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: March 2018
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research investigation is to conduct a prospective observational study of the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone for the treatment of acute undifferentiated agitation in the emergency department.

Description:

The ED will implement a treatment protocol as a quality improvement initiative. All patients requiring chemical sedation for will receive haloperidol as the initial treatment for agitation for 21 days, followed by ziprasidone as the initial treatment for agitation for 21 days, followed by olanzapine as the initial treatment for agitation for 21 days, and finally midazolam as the initial treatment for agitation for 21 days.

This is a clinical care quality improvement protocol. The research component is the observation of this clinical care protocol.

Patients who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol.

Trained Research Associates will collect all data on patients who receive a protocol medication. This will include baseline demographic data including age, gender, etiology of agitation (according to the treating physician, presumed at the time of medication administration), initial vital signs, breath alcohol level, drug screen results, pre-hospital medications administered, and any other laboratory data available at the time (e.g. glucose).

Research associates will record the patient's level of agitation using a validated agitation scale, the Altered Mental Status (AMS scale). The AMS scale is an ordinal scale ranging from -4 (profoundly somnolent) to +4 (profoundly agitated), with agitation generally defined as an AMS scale of 2 or greater. This scale is a modified version of the Observer's Assessment of Alertness Scale and the Behavioral Activity Rating Scale.

AMS scores will be recorded at the time of medication administration and at every subsequent 15-minute interval until 120 minutes. Research associates will also carry stopwatches and record the time elapsed until adequate sedation (defined as an AMS ≤ 0), as well as whether other medications (defined as "rescue medications") were administrated for any reason and at what time this occurred.

Research associates will prospectively monitor each patient for all adverse side effects of the medications, including hypoxia, need for airway intervention (nasal cannula, facemask, non-invasive positive pressure ventilation, endotracheal intubation), hypotension, cardiac dysrhythmias, extrapyramidal side effects, and other complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency Department patients (18+) with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician

Exclusion Criteria:

• Known pregnancy

• Allergy to the medication during the block

• Prisoner/under arrest

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Psychomotor Agitation

Intervention

Drug:
• Haloperidol Injection
As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive haloperidol as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
• Ziprasidone Injection
As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive ziprasidone as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
• OLANZapine Injection
As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive olanzapine as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
• Midazolam injection
As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive midazolam as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the mean difference in Altered Mental Status (AMS) score from baseline at 15 minutes post-administration for each study drugs.	Patients score on a previously validated agitation scale called the AMSS; ADDENDUM: The primary outcome for this study was changed prior to study initiation to the proportion of patients adequately sedated at 15 minutes (defined as AMSS < 1). This addendum was methodologically necessary to account for the ordinal, non-normal distribution of this data.	15 minutes
Secondary	Time to adequate sedation	The time elapsed in minutes to achieve a score of < 1 on a validated agitation scale called the AMSS	Within the 120 minutes post-medication administration
Secondary	Rescue Sedation	Proportion of patients requiring additional medication for sedation within 1 hour	1 hour